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Cases - Doing All The Right Things - For All The Wrong Reasons - The Lessons To Business
As a former CEO of a publicly-traded company, I have watched the emerging revelations of corporate wrongdoing with more than a passing interest. While filled with the same revulsion shared by many to the immo
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
ral, illegal and greedy actions of some companies and their leaders, I am also concerned that we not overreact and undercut an economic system that is clearly the best in the world. The fault, my dear readers
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
, is not with the system, but with an abuse of the system. We should also be careful to differentiate between the greedy abuse of the system and the criminal act of looting a company.
As I read attacks on st
As I read attacks on st
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
ock options and other forms of incentive compensation, my thoughts parallel the arguments of gun advocates who say, “Guns don’t kill. People kill.” Stock options don’t harm shareholders, greedy people do. Inh
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
biting or eliminating stock options and other forms of incentive compensation plans will make it more difficult for the greedy to gain, but such action will also reduce the incentive for employees to add to s
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
hareholder value. There is nothing wrong with trying to maximize corporate profits, the problem lies in doing it with lies.
From my experience, all of these issues boil down to two causes; and they are greed
From my experience, all of these issues boil down to two causes; and they are greed
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
and the system under which stocks are valued and marketed. Both of these are interwoven and feed of each other.
With the CEO and other top management there is a phenomenon of “entitlement” that can cloud th
With the CEO and other top management there is a phenomenon of “entitlement” that can cloud th
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
e thinking. Charles Shepard in his book “”Forgiven – The Rise and Fall of Jim Bakker and the PTL Ministry,” identified this feeling as the driving cause of Bakker’s downfall. Shepard pointed out that if PTL b
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ought in $5 million a month and Bakker diverted $2 million to his personal use, the rationale was, “If it were not for me, PTL would not have the $3 million that remained.”
This is a logic that can tempt man
This is a logic that can tempt man
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
y a CEO and, as we have seen, some can fall prey to this faulty logic. A number of CEOs and their management groups seemed to have adopted a philosophy that says, “Through my actions $1 billion has been added
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
to shareholder value, so it’s ok for me to take $100 million. After all, If it were not for me, the shareholders would not have that $1 billion, so I am ‘entitled’ to this reward.” Of course, allowing those
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
who add value to an organization to share in the value added is a good incentive to add value, but what we have seen is a corruption of that concept.
The inclusion of other members of senior management in
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
hese schemes is an insidious form of control. And a reverse of the “share value for value added” concept. It’s difficult to stop corruption if you benefit from the corruption.
The current system of valuing a
The current system of valuing a
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
nd marketing stock also contributes to the temptation to cut corners. I often felt the pressure from stock analysts and market makers of our stock to report consistent, increased quarterly earnings. To do so
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
offered promises of increased stock value, and deviation led to swift punishment in the form of depressed stock value.
In and off itself, this is not a bad system. Companies with increasing earnings should h
In and off itself, this is not a bad system. Companies with increasing earnings should h
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
ave increasing stock value and visa versa. The problem is the extent to which the system is so volatile. In an effort to report consistent earnings, there is encouragement to “manage” the earnings. “Squirreli
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
g” away earnings in good times and “stretching” for earnings in bad times. Either way, the shareholder does not receive a clear and accurate picture of the performance of the company, but the analyst and the
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
market gets what it wants. Taken to the extreme causes the revelations we’ve seen in recent years.
There’s a moral to this story for business owners of all sizes and their employees that make them successful
There’s a moral to this story for business owners of all sizes and their employees that make them successful
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
and it is this: Pride, arrogance and secrets have a way of undoing even those with the best intentions. While most people will never face temptations on the same scale as Tammy Faye and Jim Bakker, or the m
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
ultititude of other CEOs who fall from grace, the ingredients are often the same in small businesses and personal households. Whether large or small, they suggest there but for the grace of God, go any of us
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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